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FDA Inspection
•Intas Pharmaceuticals Limited•June 19, 2017

Intas Pharmaceuticals Limited – FDA Inspection, Jun 19, 2017

Record Details

This FDA Inspection record concerns Intas Pharmaceuticals Limited, with an inspection on June 19, 2017, issued by the Office of Inspections and Investigations, covering human drugs.

Company
Intas Pharmaceuticals Limited
Inspection Date
June 19, 2017
Product Type
Human Drugs
Office
Office of Inspections and Investigations
Person
  • William J. Leonard (Issuing Officer)
View Company Profile

ID · 238313c0-72c9-4569-810f-9034623241ce

Inspection Facts

Inspection number
1014641
FDA center
Human Drugs
Project area
Generic Drug Evaluation
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 211.110(a)Control procedures to monitor and validate performance
  2. 21 CFR 211.166(a)(1)Sample size - test intervals

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Intas Pharmaceuticals Limited

7
DateClassificationOfficeProject area
December 2, 2022OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
February 28, 2020VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
May 28, 2019VAICenter for Drug Evaluation and ResearchGeneric Drug Evaluation
October 19, 2016VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
December 19, 2014NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 7 other inspections on the company page
Other documents for Intas Pharmaceuticals Limited
  • FDA Inspection 1191818 - 2022-12-02
  • FDA Inspection 1119170 - 2020-02-28
  • FDA Inspection 1092798 - 2019-05-28
  • FDA Inspection 992746 - 2016-10-19
  • FDA Inspection 910188 - 2014-12-19

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